Results for “Highness Implant System”

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Registry EUDAMED 427 FDA 510(k) incl. De Novo 1 FDA PMA GUDID 432

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Germany 75 Poland 5 Belgium 2 Romania 1

Risk class Class I Class IIa Class IIb 347 Class III Class II (US) 341

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Class A Class B Class C Class D IVD General IVD Annex II List A IVD Annex II List B IVD for self-testing Active implantable (AIMDD) Unclassified (FDA) Not classified (FDA)

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Highness Implant System

Highness Co., Ltd.,South Korea Group of variants

Active Regimes: CE MDD Registry: EUDAMED Class:IIb
Highness Implant System

highness Co., Ltd.,South Korea Group of variants

Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED Class:IIb

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